Events

Alerta De Seguridad para Mortara Digital Holter Recorder /// ANVISA Record Number: 80288099012 /// Hazard Class: II /// Model: H3 + (Plus - CHEXXXXX) /// Lots: 115190255741/115190255742/115190255743/115190255744/115190255744/115190255746 / 115190255759/115190255760/115190255761/115190255763/115190255764/115190255767/115190255769/115190255770/115190255773/115190255777/115190255778/115190255779/115190255780/115190255787/115190255788/115190255789/115190255786/115190255800/115190255803/115190255804/115190255808/115190255809/115190255810/115190255814/115190255822 / 115190255823/115190255824/115190255826/115190255827/115190255830/115190255832/115190255833/115190255834/115190255835/115260261298/115260261299/115260261300/115260261301/115260261302/115260261303/115260261304/115260261305/115260261306/115260261307/115260261308/115260261309/115260261310/115260261311/115260261312/115260261313 / 115260261314/115260261315/115260261316/115260261317/115260261318/11 52602613119/15260261320/115260261321/115260261322/115260261323/115260261324/115260261325/115260261326/115260261327/115260261328/115260261329/115260261330/115260261331/115260261332/115260261333/115260261334/115260261335/115260261336/115260261337/115260261338/115260261339/115260261340/115260261341/115260261342/115260261343 / 115260261344/115260261346/115260261348/115260261349/115260261350/115260261351/115260261351/115260261352/115260261353/115260261354/115260261355 115260261356/115260261357.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por TKL Importação e Exportação de Produtos Médicos e Hospitalares Ltda; Mortara Instrument Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1862
  • Fecha
    2016-04-08
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
  • Causa
    According to tkl, "we received a field corrective action notice from the manufacturer" field corrective action notice "on 11/19/2015, reporting that it identified a problem with the hardware of the h3 + model equipment, which could result in a battery current higher than normal and cause the device to record less time than expected, requiring corrective repair of the equipment hardware. ".
  • Acción
    The action is being taken due to the identification of a problem in the hardware of the H3 + model, which can result in a higher than normal battery current and cause the device to record less time than expected, requiring corrective repair action device hardware. a) Risk classification III; b) Classification of the field action: Correction in Field / Correction of parts and pieces / Other situation (IncisoIV); c) Field action code: 001.16; d) recommendations to users and patients: Segregate product for service repair.

Device

Mortara Digital Holter Recorder /// ANVISA Record Number: 80288099012 /// Hazard Class: II /// Mo...

Manufacturer

TKL Importação e Exportação de Produtos Médicos e Hospitalares Ltda; Mortara Instrument Inc.
  • Source
    ANVSANVISA